Tubing system with operation mode communication

ABSTRACT

A capnography system includes a CO 2  sensing system having a CO 2  sensor configured to measure a CO 2  concentration in exhaled breath of a subject, a processor configured to derive one or more breath related parameters based on the measured CO 2  concentration, and a communication unit. The capnography system includes a tubing system configured to allow flow of respiratory gasses therethrough. The tubing system includes a connector configured to connect the tubing system to the CO 2  sensing system and a communication component configured to provide an indication of a type of the tubing system to the communication unit. The communication unit is configured to transfer data to the processor based on the indication obtained from the communication component, and the processor is configured to change or suggest a change of an operation mode of the CO 2  sensing system based on the data.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to and the benefit of U.S. ProvisionalApplication No. 62/661,732, filed on Apr. 24, 2018, the content of whichis incorporated herein by reference in its entirety for all purposes.

TECHNICAL FIELD

The present disclosure generally relates to the field of capnographysystems and uses thereof.

BACKGROUND

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present techniques,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

Measuring respiratory carbon dioxide (CO₂) of a subject providessignificant indication of metabolic-related conditions of the subject.Common capnography systems that measure respiratory CO₂ use theabsorption properties of CO₂ molecules for electromagnetic waves atcertain wavelengths to measure the concentration of CO₂ molecules withinthe respired gas. However, measuring respiratory CO₂ may be complicatedand/or altered by the tubing system and/or by medical proceduresperformed during the measuring process.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, not limiting in scope. Invarious embodiments, one or more of the above-described problems havebeen reduced or eliminated, while other embodiments are directed toother advantages or improvements.

According to some embodiments, there is provided a capnography system,including a CO₂ sensing module and a tubing system. According to someembodiments, the CO₂ sensing module may include a CO₂ sensor configuredto measure the CO₂ concentration in a subject's exhaled breath, aprocessing unit configured to derive one or more breath relatedparameters based on the measured CO₂ concentration, a pump, and acommunication unit. According to some embodiments, the tubing system maybe configured to allow flow of respiratory gasses therethrough and mayinclude a connector configured to connect the tubing system to the CO₂sensing module and a communication component configured to provide anindication of a type of the tubing system to the communication unit whenthe tubing system is connected to the CO₂ sensing module.Advantageously, the communication unit may be configured to transferdata to the processing unit based on the indication obtained from thecommunication component, and the processing unit may be configured tochange or suggest a change of an operation mode of the CO₂ sensingmodule based on the transferred data.

According to some embodiments, the tubing system may include anintubation tube. According to some embodiments, changing an operationmode of the CO₂ sensing module may include enhancing or suggesting anenhancement of the operation of the pump upon intubation and until afirst CO₂ signal is obtained, thereby reducing a time required forverification of correct intubation.

According to some embodiments, the tubing system may include or be abite block, and changing an operation mode of the CO₂ sensing module mayinclude identifying CO₂ concentration peaks resulting from CO₂insufflation of the subject and/or applying/initiating or suggesting useof an algorithm configured to reduce nuisance alarms duringinsufflation.

According to some embodiments, the tubing system may include or be anoral nasal cannula and changing an operation mode of the CO₂ sensingmodule may include identifying high respiration rates resulting frompain and/or applying/initiating or suggesting use of an algorithmconfigured to reduce nuisance alarms during pain management.

According to some embodiments, the tubing system may include or be anoxygen supply tube and changing an operation mode of the CO₂ sensingmodule may include identifying aberrations in the CO₂ measurementsresulting from dilution of the exhaled breath with oxygen and/orapplying/initiating or suggesting use of an algorithm configured tocorrect/normalize/adjust the one or more breath related parameters,based on the identified dilution.

According to some embodiments, the data may be encrypted.

According to some embodiments, the communication component may befurther configured to provide a second indication regarding a propertyof the tubing system to the communication unit, and the processing unitmay be further configured to adjust or suggest adjustment of theoperation mode of the CO₂ sensing module based on the second indication.According to some embodiments, the property of the tubing system may bea length of the tubing system, a diameter of the tubing system, a targetgroup of the tubing system, an intended duration of the tubing system,or any combination thereof.

According to some embodiments, the communication component is furtherconfigured to provide a third indication regarding a manufacturingdetail of the tubing system to the communication unit. According to someembodiments, the manufacturing detail may include or be production site,production date, production station, lot number, serial number,expiration date, or any combination thereof.

According to some embodiments, the communication component may befurther configured to transfer usage data to the communication unitand/or the processing unit. According to some embodiments, the usagedata may include or be a number of occlusion of the tubing system,duration of use, number of uses/connections of the tubing system to aCO₂ sensing module, or any combination thereof.

According to some embodiments, the processing unit and/or thecommunication unit may be configured to communicate a signal terminatingthe usability of the tubing system, when the operational data indicatesthat the tubing system has run obsolete. According to some embodiments,terminating the usability may include destroying the communicationcomponent of the tubing system.

According to some embodiments, the processing unit may be furtherconfigured to transfer the operational data and the manufacturing detailto a remote computational unit. According to some embodiments, theremote computational unit may be configured to integrate the operationaldata with the manufacturing detail, thereby enabling identification ofmanufacturing problems causing defects in the tubing system and/orenabling identification of defected tubing system prior to their useand/or distribution.

According to some embodiments, the capnography system may furtherinclude a user interface (UI) configured to receive the suggested changein the operational mode of the CO₂ sensing module and, optionally, toallow a user to implement, adjust, or overrule the suggested change.

According to some embodiments, the communication component comprises a1-wire electrically erasable programmable read-only memory (EEPROM).

According to some embodiments, there is provided a processing moduleincluding computer executable software configured to receive, from asensing module, an indication of a type of the tubing system connectedto the sensing module and to change or to suggest a change of anoperation mode of the CO₂ sensing module based on the indication.

As a non-limiting example, the processing module may receive anindication that a tubing system including an intubation tube isconnected to the CO₂ sensing module and accordingly enhance or suggestan enhancement of the operation of a pump functionally connected to theintubation tube, upon intubation and until a first CO₂ signal isobtained, thereby advantageously reducing a time required forverification of correct intubation.

As another non-limiting example, the processing module may receive anindication that a tubing system including a bite block is connected tothe CO₂ sensing module and accordingly apply or suggest applying analgorithm identifying CO₂ concentration peaks resulting from CO₂insufflation of the subject, thus advantageously enabling a reduction innuisance alarms during CO₂ insufflation.

According to some embodiments, the data received by the processingmodule may be encrypted.

According to some embodiments, the processing module may be furtherconfigured receive an indication regarding a property of the tubingsystem to the communication unit, and to trigger or suggest adjustmentof an operation mode of the CO₂ sensing module, based on the indication.According to some embodiments, the property of the tubing system may bea length of the tubing system, a diameter of the tubing system, a targetgroup of the tubing system, an intended duration of the tubing system,or any combination thereof.

According to some embodiments, the processing module may be furtherconfigured receive an indication regarding a manufacturing detail of thetubing system. According to some embodiments, the manufacturing detailmay include or be production site, production date, production station,lot number, serial number, expiration date, or any combination thereof.

According to some embodiments, the processing module may be furtherconfigured receive usage data of the tubing system including, forexample, a number of occlusion of the tubing system, duration of use,number of uses/connections of the tubing system to a CO₂ sensing module,or any combination thereof. According to some embodiments, theprocessing module may be further configured to trigger or suggestadjustment of the CO₂ sensing module, based on the usage data.

According to some embodiments, the processing unit may be configured tocommunicate a signal terminating the usability of the tubing system whenthe operational data indicates that the tubing system has run obsolete.According to some embodiments, terminating the usability may includedestroying the communication component of the tubing system.

According to some embodiments, the processing unit may be furtherconfigured to transfer the operational data and the manufacturing detailto a remote computational unit. According to some embodiments, theremote computational unit may be configured to integrate the operationaldata with the manufacturing detail, thereby enabling identification ofmanufacturing problems causing defects in the tubing system and/orenabling identification of defected tubing system prior to their useand/or distribution.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more technical advantages may bereadily apparent to those skilled in the art from the figures,descriptions and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some or none of the enumerated advantages.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed descriptions.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples illustrative of embodiments are described below with referenceto figures attached hereto. In the figures, identical structures,elements, or parts that appear in more than one figure are generallylabeled with a same numeral in all the figures in which they appear.Alternatively, elements or parts that appear in more than one figure maybe labeled with different numerals in the different figures in whichthey appear. Dimensions of components and features shown in the figuresare generally chosen for convenience and clarity of presentation and arenot necessarily shown in scale. The figures are listed below.

FIG. 1 schematically illustrates a functional block-diagram of acapnography system, according to some embodiments;

FIG. 2 is a flowchart of the steps of a method for capnography,according to some embodiments; and

FIG. 3 is a graph showing experimental CO₂ readings measured during aCO₂ insufflation procedure.

DETAILED DESCRIPTION

In the following description, various aspects of the disclosure will bedescribed. For the purpose of explanation, specific configurations anddetails are set forth in order to provide a thorough understanding ofthe different aspects of the disclosure. However, it will also beapparent to one skilled in the art that the disclosure may be practicedwithout specific details being presented herein. Furthermore, well-knownfeatures may be omitted or simplified in order not to obscure thedisclosure.

According to some embodiments, there is provided a capnography system,comprising a CO₂ sensing module and a tubing system. The CO₂ sensingmodule includes a CO₂ sensor configured to measure a CO₂ concentrationin a subject's exhaled breath, a processing unit configured to deriveone or more breath related parameters based on the measured CO₂concentration, a pump, and a communication unit. The tubing system isconfigured to allow flow of respiratory gasses therethrough, andincludes a connector configured to connect the tubing system to the CO₂sensing module and a communication component configured to provide anindication to the communication unit regarding the type of the tubingsystem connected. The communication unit is configured to transfer datato the processing unit based on the indication obtained from thecommunication component. The transferred data is utilized by theprocessing unit to change or suggest a change of an operation mode ofthe CO₂ sensing module based on the transferred data.

Advantageously, the herein disclosed capnography system enablescommunication, optionally in both directions, between the tubing systemand the CO₂ sensing module to which it is connected. This may enable oneto specify and/or custom fit the operation mode of the CO₂ sensingmodule according to the tubing system attached and/or its medicalapplication by implementing sample line specific algorithms and/orfeatures based on the type of consumable connected.

According to some embodiments, the communication component may beconfigured to store, receive, and/or transfer data. Each possibility isa separate embodiment.

According to some embodiments, the communication component may befurther configured to provide a second indication regarding a propertyof the tubing system, such as, but not limited to, a length of asampling tube, a diameter of the tubing system, a target group of thetubing system, an intended duration of use of the tubing system, or anycombination thereof. Each possibility is a separate embodiment.According to some embodiments, the processing unit may be furtherconfigured to adjust or suggest adjustment of the operation mode of theCO₂ sensing module based on the second indication.

As a non-limiting example, in upper gastro-intestinal proceduresrequiring use of a bite block, a common problem is the prevalence ofspikes in the CO₂ concentration measurements due to the insufflation ofthe patient with CO₂. Communication between the bite block tubing andthe CO₂ sensing module may advantageously enable customizing theoperation mode of the CO₂ sensing module to implement algorithms, whichenable disregarding and/or designating the spikes as artifacts caused bythe insufflation, thereby preventing or reducing triggering of nuisancealarms.

Similarly, in emergency settings (EMS), where patients undergointubation, the appearance of a CO₂ reading typically serves asverification of correct intubation. However, when utilizing side streamcapnography, the relatively long response time due to the travel of thebreath sample through the sampling tube, may delay the verificationwhich may be critical in situations where reintubation is required.Communication between the intubation tubing and the CO₂ sensing modulemay advantageously enable customizing the operation mode of the CO₂sensing module to trigger the increasing of the pumping speed until afirst reading is obtained, thereby significantly decreasing the responsetime and thus the time required for verification of correct intubation.It is noted that an increasing of the pumping speed may be applicablefor intubation of adults only. Accordingly, the communication component(whether the same or a different component) may further provide dataregarding a property of the attached tube, such as the intubation tubebeing for use in adults or neonates, and to trigger the increasing ofthe pumping speed only when an intubation tube for use in adults isconnected.

As an additional example, at the general care floor (GCF) and/orpost-operative settings, patients suffering from pain and/or undergoingpain management may experience elevated respiration rates that are notassociated with pathologic breathing, yet may be interpreted as such andoften result in an unnecessary triggering of an alarm. Communicationbetween the breath sampling tubing and the CO₂ sensing module mayadvantageously enable customizing the operation mode of the CO₂ sensingmodule to implement algorithms which enable disregarding and/ordesignating the elevated respiration rate as an artifact, therebypreventing/reducing the triggering of nuisance alarms.

According to some embodiments, the adjustment and/or change in theoperation mode of the CO₂ sensing module may be automatically activatedby the connection of the specific tubing to the CO₂ sensing modulewithout requiring any user intervention or changes on the host monitordesign. Alternatively, the sample line specific algorithms and/orfeatures may be in the form of recommendations (for example, presentedto the user on a monitor of a UI), and the implementing of thealgorithms and/or features may require the consent of the user. Byallowing a user feedback, a user may discard/overrule the suggestedchange or modify it based on the user's professionalperception/judgement of the patient's needs.

According to some embodiments, the data may be encrypted. As anon-limiting example, the data transferred by the communication unit tothe processing unit and/or to the remote compute unit and vice versa maybe encrypted, thereby securing it from user interference.

According to some embodiments, the communication component may befurther configured to provide a third indication regarding amanufacturing detail of the tubing system to the communication unit.Non-limiting examples of suitable manufacturing details includeproduction site, production date, production station, lot number, serialnumber, expiration date, or any combination thereof. Each possibility isa separate embodiment.

According to some embodiments, the communication unit may be furtherconfigured to transfer the third indication regarding the manufacturingdetail to a remote computing unit for storage and/or further analysis.It is understood that the remote computing unit may use the transferreddata for quality control analysis. As a non-limiting example, the remotecomputing unit may be programmed via software to analyze themanufacturing quality of a particular manufacturing site, by correlatingthe performance of tubing systems with the manufacturing site. Asanother non-limiting example, the remote computing unit may beprogrammed via software to identify tubing systems belonging to a lotwith manufacturing defects, by correlating the performance of tubingsystems with the manufacturing site. As another non-limiting example,the remote computing unit may be programmed via software to manageproduction and/or storage parameters by monitoring the serial number,lot number, and/or expiration date of tubing system being used.According to some embodiments, the remote unit may back-communicate userinstructions to a user-interphase based on the quality control analysis.For example, once a lot with defects has being identified, plugging inthe tubing system belonging to the defect lot may result in a messagepopping up on the host monitor notifying the user of the defect,optionally in conjunction with a recommendation to discard the tubingsystem. Additionally or alternatively, the remote unit and/or the userinterface may back-communicate data to the communication component ofthe tubing system itself. As a non-limiting example, plugging in anoutdated tubing system may result in an automatic disposal/terminatingits usability of the tubing system, thus preventing its misuse. Asanother non-limiting example, plugging in an outdated tubing system mayresult in an inactivation of the CO₂ sensing module. According to someembodiments, plugging in an outdated tubing system may result in thecommunication component of the tubing system sending a notification tothe CO₂ sensing module and/or to the host monitor.

According to some embodiments, the communication component may befurther configured to transfer usage data (also referred to herein asperformance data) to the CO₂ sensing module's communication unit and/orprocessing unit. Non-limiting examples of suitable usage data includenumber of occlusions of the tubing system, duration of use, number ofuses/connections of the tubing system to a CO₂ sensing module, or anycombination thereof. Each possibility is a separate embodiment.According to some embodiments, the communication unit may be furtherconfigured to transfer the usage data to a remote computing unit (and/ora user interface) for storage and/or further analysis. According to someembodiments, the remote computing unit may use the performance data forquality control analysis. As a non-limiting example, the remotecomputing unit may be programmed via software to analyze themanufacturing quality of a particular manufacturing site by correlatingthe performance of tubing systems with the manufacturing site.

According to some embodiments, the communication unit may control theusage of the tubing data based on the transferred performance dataduring use. As a non-limiting example, the tubing system or the CO₂sensing module may include a pressure sensor configured to detectpressure changes in the tubing system, which pressure changes resultfrom occlusions/blockages in the tubing system. According to someembodiments, once recurring occlusions/blockages of the tubing areidentified, the communication unit of the CO₂ sensing module may beconfigured to transfer/trigger a message to pop on up on the hostmonitor notifying the user of the tubing system having reachedsaturation, optionally in conjunction with a recommendation to discardthe tubing system. Additionally or alternatively, the communication unitmay back-communicate data to the communication component causing itsabolishment and/or changing its status, thus preventing misuse. Asanother non-limiting example, the communication component may beconfigured to transfer the duration of use to the communication unit.The communication unit may then, once an upper limit of use has beenreached and/or approaching, trigger a message to pop on up on the hostmonitor notifying the user of the tubing system having reachedsaturation, optionally in conjunction with a recommendation to discardthe tubing system. Additionally or alternatively, the communication unitmay back-communicate data to the communication component causing itsabolishment/terminating its usability and/or change its status once anupper limit of use has been reached, thus preventing potentiallyhazardous continued use of the tubing system.

According to some embodiments, discarding, disposing, abolishing, andterminating the usability of a tubing system may include destroying thecommunication component of the tubing system, thus preventing it frombeing recognized by the CO₂ sensing module. According to someembodiments, discarding, disposing, abolishing, and terminating theusability of a tubing system may include changing a status (e.g. tubeblocked), which change in status may be identified by the CO₂ sensingmodule. According to some embodiments, the change in status maycause/trigger the CO₂ sensing module to notify the host monitor of thechanged status. According to some embodiments, the change in status maycause inactivation of the CO₂ sensing module. According to someembodiments, the change in status may cause/trigger the CO₂ sensingmodule to notify the host monitor of the changed status.

According to some embodiments, the communication link may include or bea communication bus, such as a serial communication bus. According tosome embodiments, the serial communication bus may be a 1-wire bus.According to some embodiments, the serial communication bus may be anEEPROM, such as, but not limited to, a 1-wire EEPROM. According to someembodiments, the serial communication bus may be an inter-integratedcircuit (I₂C) bus, a universal asynchronous receiver-transmitter (UART)bus, an serial peripheral interface (SPI) bus, or the like. According tosome embodiments, the communication link may include near-fieldcommunication (NFC) or radio-frequency identification (RFID).

According to some embodiments, the communication unit facilitates a buscommunication protocol. According to some embodiments, the communicationunit facilitates a master/slave communication protocol, wherein thecommunication component in the consumable is a communication slavecomponent and the communication unit of the CO₂ sensing module is amaster communication controller. According to some embodiments, thecommunication unit is configured to manage the communication on thecommunication component.

Reference is now made to FIG. 1 , which schematically illustrates afunctional block-diagram of a capnography system 100, according to someembodiments. According to some embodiments, the capnography system 100includes a communication component 102 in communication with a CO₂sensing module 104 (e.g., CO₂ sensing system). The CO₂ sensing module104 is configured to be in communication with a host monitor 106 and aremote computing unit 108. According to some embodiments, communicationof the CO₂ sensing module 104 and the remote computing unit 108 utilizescloud-based security solutions.

The CO₂ sensing module 104 is configured to obtain information providedby the communication component 102 regarding a tubing system connectedthereto, and analyze it for a clinical application purpose 110,consumable authentication purpose 116, consumable management purpose120, and/or the like.

According to some embodiments, the CO₂ sensing module 104 is configuredto identify a desired clinical application 110 based on an indication ofa type of a tubing system 112 connected thereto, as received fromcommunication component 102, and to adjust or maintain an operation modethereof to comply with the desired clinical application. According tosome embodiments, the CO₂ sensing module 104 changes or suggests achange of the operation mode. According to some embodiments, the CO₂sensing module 104 is further configured to transfer data based on thereceived indication to the host monitor 106 and/or the remote computingunit 108. According to some embodiments, the CO₂ sensing module 104 isconfigured to trigger a user notification message 114 on the hostmonitor 106 notifying a user on a suggested operation mode or on acurrent operation mode or on a change/adjustment of the operation mode,based on the identified desired clinical application. According to someembodiments, a user is allowed to implement, adjust, or overrule thesuggested change/adjustment. Optionally, the host monitor 106 allows auser to access a device management unit 128 to control/manage theoperation mode. Optionally, the host monitor 106 is configured for datatransfer 130 to the remote computing unit 108.

According to some embodiments, the CO₂ sensing module 104 is configuredfor consumable authentication 116 based on a manufacturing detail of atubing system 118 connected thereto, which is received from thecommunication component 102. For the purpose of authentication, amanufacturing detail may include at least one of production site,production date, production station, lot number, serial number,expiration date, any combination thereof, or any other identificationkey. According to some embodiments, once no manufacturing detail of thetubing is authenticated/identified, CO₂ sensing module 104 may beconfigured to terminate or suggest termination of usability of thetubing system. Alternatively, devoid authentication, the CO₂ sensingmodule 104 may fail to initiate. Additionally or alternatively, the CO₂sensing module 104 may back-communicate data to the communicationcomponent 102, causing its abolishment/terminating its usability and/orchange of its status when authentication is not validated, thuspreventing potentially hazardous non-compatible use of the tubingsystem. According to some embodiments, the CO₂ sensing module 104 isfurther configured to transfer data based on the consumableauthentication 116 to host the monitor 106 and/or the remote computingunit 108. According to some embodiments, the CO₂ sensing module 104 isconfigured to trigger a display of a user notification message 114 onthe host monitor 106 notifying a user on authentication results and,optionally in case of an authentication problem, in conjunction with amessage on termination of usage or a suggested termination of use.According to some embodiments, a user is allowed to implement, adjust,or overrule the suggested termination of use.

According to some embodiments, the CO₂ sensing module 104 is configuredfor consumable management 120 based on an information of a property of atubing system 122 connected thereto received from the communicationcomponent 102 and to maintain, adjust, or suggest adjustment of anoperation mode thereof to comply with the property of the tubing system.Non-limiting examples of properties include a length of a sampling tube,a diameter of the tubing system, a target group of the tubing system, anintended duration of use of the tubing system, or any combinationthereof.

According to some embodiments, the CO₂ sensing module 104 is configuredfor consumable management 120 based on a usage data 124 of a tubingsystem connected thereto received from the communication component 102.Non-limiting examples of usage data include number of occlusions of thetubing system connected thereto, duration of use, number ofuses/connections of the tubing system to a CO₂ sensing module, or anycombination thereof. Once an upper limit of use has been reached and/orapproached, the CO₂ sensing module 104 may trigger a display of a usernotification message 114 on the host monitor 106 notifying the user ofthe tubing system having reached saturation, optionally in conjunctionwith a recommendation to discard the tubing system. According to someembodiments, the CO₂ sensing module 104 may back-communicate data to thecommunication component 102 causing its abolishment/terminating itsusability and/or a change in its status, once an upper limit of use hasbeen reached, thus preventing potentially hazardous continued use of thetubing system. Additionally or alternatively, the CO₂ sensing module 104is configured for determining/monitoring a usage data of a tubing systemconnected thereto (option not shown). According to some embodiments, theCO₂ sensing module 104 may be further configured to transfer usage data124 to the remote computational unit 108 and/or the host monitor 106 forstorage and/or further analysis.

According to some embodiments, the remote computational unit 108 isconfigured for quality control 126 based on integration of a usage data124 with a manufacturing detail 118, thereby enabling identification ofmanufacturing problems causing defects in the tubing system and/orenable identification of a defected tubing system prior to their useand/or distribution. According to some embodiments, the remotecomputational unit 108 is configured to back-communicate userinstructions to the CO₂ sensing module 104 based on the quality controlanalysis.

As used herein, the terms “consumable” and “tubing system” areinterchangeable.

Reference is now made to FIG. 2 , which is a flowchart of the steps of amethod 200 for capnography, according to some embodiments. The method200 may be carried out by the capnography system 100 of FIG. 1 .

A desired clinical application is identified and operation mode of thecapnography system is adjusted to comply with the identified desiredclinical application based on information received from a communicationcomponent connected thereto (step 202). Optionally, the receivedinformation is an indication of a type of the consumable connected tothe capnography system. An operation mode of the capnography system isadjusted or adjustment is suggested to comply with a property of theconsumable based on information received from the communicationcomponent (step 204). Non-limiting examples of properties include alength of a sampling tube, a diameter of the tubing system, a targetgroup of the tubing system, an intended duration of use of the tubingsystem, or any combination thereof. Usability of the consumable ismanaged based on a usage data of the consumable received from thecommunication component (step 206). Non-limiting examples of usage datainclude a number of occlusions of the tubing system connected thereto, aduration of use, a number of uses/connections of the tubing system to aCO₂ sensing module, or any combination thereof. Optionally, when anupper limit of use has been reached and/or approached, usability of theconsumable is terminated or a termination is suggested. Usability of theconsumable is managed based on a quality control data corresponding to amanufacturing detail of the consumable received from the communicationcomponent (step 208). Optionally, the usability of the consumable ismaintained or terminated, or an operational mode may be adjusted tocomply with operation of the consumable. Each of the options may beautomatically performed or alternatively suggested to a user.Optionally, the quality control data is based on analysis of usage dataof consumables with the same manufacturing detail. Optionally, thequality control data is analyzed by a remote computing system andcommunicated to the communication component.

Each of the steps may result in termination of use or in suggestion oftermination of use. Each of steps 202, 204, 206, and 208 may beperformed in an interchangeable order in parallel or in sequence.Furthermore, one or more of the steps 202, 204, 206, and 208 may beomitted from and/or additional steps may be added to the method 200.

For example, optionally, the method 200 further comprises a preliminarystep of authenticating a consumable connected to a capnography systembased on a manufacturing detail of the consumable. For the purpose ofauthentication, a manufacturing detail may include at least one ofproduction site, production date, production station, lot number, serialnumber, expiration date, any combination thereof, or any otheridentification key. Optionally, when the manufacturing detail is notvalidated, the usability of the consumable may be terminated ortermination of usability is suggested.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a,” “an,” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise. It willbe further understood that the terms “comprises” or “comprising,” whenused in this application, specify the presence of stated features,integers, steps, operations, elements, or components, but do notpreclude or rule out the presence or addition of one or more otherfeatures, integers, steps, operations, elements, components, or groupsthereof.

Unless specifically stated otherwise, as apparent from the followingdiscussions, it is appreciated that throughout the specificationdiscussions utilizing terms such as “processing,” “computing,”“calculating,” “determining,” “estimating,” or the like, refer to theaction and/or processes of a computer or computing system, or similarelectronic computing device, that manipulate and/or transform datarepresented as physical, such as electronic quantities within thecomputing system's registers and/or memories, into other data similarlyrepresented as physical quantities within the computing system'smemories, registers, or other such information storage, transmission, ordisplay devices.

Embodiments of the present disclosure may include apparatuses forperforming the operations herein. This apparatus may be speciallyconstructed for the desired purposes, or it may comprise a generalpurpose computer selectively activated or reconfigured by a computerprogram stored in the computer. Such a computer program may be stored ina computer readable storage medium, such as, but not limited to, anytype of disk including floppy disks, optical disks, compact discs withread-only memory (CD-ROMs), magnetic-optical disks, read-only memories(ROMs), random access memories (RAMs), electrically programmableread-only memories (EPROMs), EEPROMs, magnetic or optical cards, or anyother type of media suitable for storing electronic instructions, andcapable of being coupled to a computer system bus. For example, thecurrent embodiments may be implemented by one or more computerprocessors that implement one or more machine-readable instructionsstored on a tangible, non-transitory, machine-readable medium and/or byspecialized circuitry designed to implement the discussed features. Theprocessing unit may include one or more processors.

The processes and displays presented herein are not inherently relatedto any particular computer or other apparatus. Various general purposesystems may be used with programs in accordance with the teachingsherein, or it may prove convenient to construct a more specializedapparatus to perform the desired method. The desired structure for avariety of these systems will appear from the description herein. Inaddition, embodiments of the present disclosure are not described withreference to any particular programming language. It will be appreciatedthat a variety of programming languages may be used to implement theteachings of the embodiments as described herein.

The embodiments may be described in the general context ofcomputer-executable instructions, such as program modules, beingexecuted by a computer. Generally, program modules include routines,programs, objects, components, data structures, and so forth, whichperform particular tasks or implement particular abstract data types.The embodiments may also be practiced in distributed computingenvironments where tasks are performed by remote processing devices thatare linked through a communications network. In a distributed computingenvironment, program modules may be located in both local and remotecomputer storage media including memory storage devices.

While a number of exemplary aspects and embodiments have been discussedabove, those of skill in the art will recognize certain modifications,additions and sub-combinations thereof. It is therefore intended thatthe following appended claims and claims hereafter introduced beinterpreted to include all such modifications, additions andsub-combinations as are within their true spirit and scope.

EXAMPLES

Reference is now made to the following examples which, together with theabove descriptions, illustrate the embodiments in a non-limitingfashion.

Example 1

Trials were performed in order to assess the efficiency and/or efficacyof utilizing a communication component for indicating use of thecapnography system during a CO₂ insufflation procedure, therebycustomizing operation of the capnography system to reduce EtCO₂ nuisancealarm during insufflation. To this end, the CO₂ sensing module wasconfigured to include an algorithm capable of identifying and filteringout artifacts in the CO₂ concentration resulting from insufflation withCO₂ (rather than respiratory complications), the algorithm beingdedicated for use in upper gastro-intestinal procedures utilizing biteblock containing tubing. As demonstrated in FIG. 3 , the modified CO₂sensing module was capable of identifying the spikes as artifacts, thusconfirming it as suitable for use in an operation mode customized forupper gastro-intestinal procedures, thereby reducing triggering ofnuisance alarms.

It is noted that initial identification of the tubing system may becritical and/or useful prior to applying the algorithms. For example,filtering out artifacts during data processing, without prioridentification of the tubing system, may not provide a desirable levelof accuracy.

Example 2

Trials were performed in order to assess the efficiency and/or efficacyof utilizing the communication component for indicating use of thecapnography system during emergency settings (EMS) in order to reducetime for verification of correct intubation. Customizing the operationmode of capnography systems to include there herein disclosedcommunication component resulted in a reduction in the average time forverification of correct intubation by approximately 25 percent and 12percent, regardless of tubing length. The pump in capnography modules,as in other electromechanical devices, is often designed to workat/around an optimal point, below its full capacity. This may be thepump's best efficiency point or set according to a desire to reduce thepump size or minimize acoustic noise generated by the pump. Since thepump is not operating at full capacity under normal conditions, it ispossible to increase the pump's output, thus increasing the flow of thesampled air, thereby reducing the response time. Increasing the pump'soutput to its full limit (e.g., upper limit) is permissible over shortintervals of time; however, continued operation of the pump at the fulllimit of the pump's output may adversely affect system operation (e.g.,reliability, wear). Additionally, increasing the flow of the sampled airmay not be suitable for some patient populations, such as neonates.Accordingly, the ability of the system to identify the tubing system,and to activate the “maximum pump output” feature only when a tubingsystem intended for use with certain types of patients (e.g., adultpatients) is identified, may provide various advantages.

The invention claimed is:
 1. A capnography system, comprising: a carbondioxide (CO₂) sensing system comprising: a CO₂ sensor configured tomeasure a CO₂ concentration in exhaled breath of a subject; a processorconfigured to derive one or more breath related parameters based on themeasured CO₂ concentration; and a communication unit; and a tubingsystem configured to enable flow of respiratory gasses therethrough, thetubing system comprising: a connector configured to connect the tubingsystem to the CO₂ sensing system; and a communication componentconfigured to provide an indication of a type of the tubing system tothe communication unit when the tubing system is connected to the CO₂sensing system; wherein the communication unit is configured to transferdata to the processor based on the indication received from thecommunication component, and wherein the processor is configured tochange or suggest a change of an operation mode of the CO₂ sensingsystem during operation thereof based on the data, and furthercomprising a user interface (UI) configured to receive the suggestedchange in the operation mode of the CO₂ sensing system and to allow auser to implement, adjust, or overrule the suggested change.
 2. Thesystem of claim 1, wherein the tubing system comprises an intubationtube, and wherein changing the operation mode of the CO₂ sensing systemcomprises enhancing or suggesting an enhancement of an operation of apump of the CO₂ sensing system upon intubation and until a first CO₂signal is obtained by the CO₂ sensor, thereby reducing a time requiredfor verification of correct intubation.
 3. The system of claim 1,wherein the tubing system comprises a bite block, and wherein changingthe operation mode of the CO₂ sensing system comprises identifying CO₂concentration peaks resulting from insufflation of the subject and/orapplying/initiating or suggesting use of an algorithm configured toreduce nuisance alarms during insufflation.
 4. The system of claim 1,wherein the tubing system comprises an oral nasal cannula, and whereinchanging the operation mode of the CO₂ sensing system comprisesidentifying high respiration rate resulting from pain and/orapplying/initiating or suggesting use of an algorithm configured toreduce nuisance alarms during pain management.
 5. The system of claim 1,wherein the tubing system comprises an oxygen supply tube, and whereinchanging the operation mode of the CO₂ sensing system comprisesidentifying aberrations in CO₂ measurements resulting from dilution ofthe exhaled breath with oxygen and/or applying/initiating or suggestinguse of an algorithm configured to correct/normalize/adjust the one ormore breath related parameters based on the identified dilution.
 6. Thesystem of claim 1, wherein the data is encrypted.
 7. The system of claim1, wherein the communication component is further configured to providea second indication regarding a property of the tubing system to thecommunication unit, and wherein the processor is further configured toadjust or suggest adjustment of the operation mode of the CO₂ sensingsystem based on the second indication.
 8. The system of claim 7, whereinthe property of the tubing system comprises a length of the tubingsystem, a diameter of the tubing system, a target group of the tubingsystem, an intended duration of the tubing system, or any combinationthereof.
 9. The system of claim 7, wherein the communication componentis further configured to provide a third indication regarding amanufacturing detail of the tubing system to the communication unit. 10.The system of claim 9, wherein the manufacturing detail comprises aproduction site, a production date, a production station, a lot number,a serial number, an expiration date, or any combination thereof.
 11. Thesystem of claim 1, wherein the communication component is furtherconfigured to transfer usage data to the communication unit and/or theprocessor.
 12. The system of claim 11, wherein the usage data comprisesa number of occlusion of the tubing system, a duration of use, a numberof uses/connections of the tubing system to a CO₂ sensing system, or anycombination thereof.
 13. The system of claim 11, wherein the processorand/or the communication unit is configured to communicate a signalterminating the usability of the tubing system, when the operationaldata indicates that the tubing system has run obsolete.
 14. The systemof claim 13, wherein terminating the usability comprises destroying thecommunication component of the tubing system.
 15. The system of claim 1,wherein the processor is further configured to transfer operational dataand a manufacturing detail to a remote computational unit, and whereinthe remote computational unit is configured to integrate the operationaldata with the manufacturing detail, thereby enabling identification ofmanufacturing problems causing defects in the tubing system and/orenabling identification of defected tubing system prior to their useand/or distribution.
 16. The system of claim 1, wherein thecommunication component comprises a 1-wire electrically erasableprogrammable read-only memory (EEPROM).
 17. A carbon dioxide (CO₂)sensing system comprising: a CO₂ sensor configured to measure a CO₂concentration in exhaled breath of a subject; a processor configured toderive one or more breath related parameters based on the CO₂concentration; and a communication unit; wherein the CO₂ sensing systemis configured to receive a connector of a tubing system comprising acommunication component, and wherein the communication unit isconfigured to receive an indication from the communication component andtransfer data to the processor based on the indication, and wherein theprocessor is configured to change or suggest a change of an operationmode of the CO₂ sensing system during operation thereof based on thedata, and further comprising a user interface (UI) configured to receivethe suggested change in the operation mode of the CO₂ sensing system andto allow a user to implement, adjust, or overrule the suggested change.18. The CO₂ sensing system of claim 17, comprising a pump configured toadjust a flow of the exhaled breath of the subject toward the CO₂sensor, wherein the processor is configured to change or suggest thechange in the operation of the pump based on the data.
 19. The CO₂sensing system of claim 18, wherein the processor is configured tochange or suggest the change in the operation of the pump in response tothe data indicating that intubation of the subject via an intubationtube of the tubing system has occurred.
 20. The CO₂ sensing system ofclaim 19, wherein the processor is configured to change or suggest thechange in the operation of the pump to increase a pumping rate toincrease the flow of the exhaled breath through the intubation tubetoward the CO₂ sensor until a first reading of the CO₂ concentration inthe exhaled breath of the subject is obtained.